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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are often described as a focus on the practical aspects of design which include recruitment and consent, adherence and the use routinely available equipment.
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A practical trial that employs different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, that is crucial for pragmatic trials to be valid and lessen the chance of bias is also essential. A high degree of heterogeneity, however can result in problems with the trial design.
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The purpose of pragmatic trials is to mimic real-life scenarios and gain maximum credibility externally. Usually, they are commissioned by policymakers and practitioners in order to inform their decisions. They are also a good method to determine the causality between an intervention and its results. However, they should not be used in lieu for explanatory studies.
The pragmatism concept is controversial and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which prove the validity of a physiological or clinical hypothesis, and pragmatic trials, that inform policy and practice decision-making. They also proposed the framework for pragmatic trials, which they called PRECIS.2 This tool was designed to define the features of a pragmatic study which includes the recruitment process, the design and delivery of the intervention, as well as the follow-up.
There is a growing trend in the number of pragmatic trials that are published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) produced 34 articles, 프라그마틱 이미지 as shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatism. It is important to keep in mind, however, that the majority of these studies were conducted in primary care settings.